A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media

• Sponsor: Abbott (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00644943
• Collaborator: (none)
• Enrollment: 425
• Locations: 32
• Arms: 2
• Patients Per Site: 13.3

Study Details

Study Description

Brief Summary

The primary objective is to compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg/day ql2hrs for 5 days, to amoxicillin/clavulanate oral suspension 45 mg/kg/day (based on amoxicillin component), in divided doses, q12h for 10 days, in children between 6 months and 6 years of age, with AOM.

Condition or Disease	Intervention/Treatment	Phase
Acute Otitis Media	Drug: cefdinir (Omnicef); Drug: amoxicillin	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 425 participants
• Allocation: Randomized
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: A Comparison of the Safety and Efficacy of Cefdinir Oral Suspension Versus Amoxicillin/Clavulanate in Pediatric Subjects With Acute Otitis Media
• Study Start Date: Feb 1, 2003
• Actual Primary Completion Date: Apr 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1	Drug: cefdinir (Omnicef); oral suspension (7 mg/kg, ql2hr) for 5 days; Other Names: ABT-198 Omnicef cefdinir
Active Comparator: 2	Drug: amoxicillin; oral suspension (45 mg/kg/day, q l2 hours) for 10 days

Outcome Measures

Primary Outcome Measures

1. Clinical Cure Rate [9 days]

Secondary Outcome Measures

1. Sustained Clinical Cure Rate [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Months to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Clinical diagnosis, documented by medical history and physical examination, is acute otitis media <=1 week

• Clinical signs and symptoms include >=1 of the following: ear pain; ear fullness, decreased hearing, or discharge from the external auditory canal (following acute perforation of the tympanic membrane).

• At least two of the following conditions are present in at least one ear: bulging tympanic membrane, which may have redness; loss of the normal light reflex and tympanic membrane landmarks and abnormal tympanic membrane mobility on biphasic pneumatic otoscopy, due to the presence of pus or fluid behind it and edema of the tympanic membrane.

• Have evidence of middle ear fluid demonstrated by acoustic reflect-tympometry.

• Generally in good health based on medical history, vital signs, physical exam, and historical laboratory results

Exclusion Criteria:

• Previous enrollment in this study.

• Enrollment in any other investigational study using unapproved products or unapproved doses, including investigational vaccines in the previous four weeks prior to study start.

• Hypersensitivity reactions to cefdinir, other cephalosporins, penicillins, other drugs, and/or sensitivity to multiple allergens.

• Presence of tympanostomy tubes or otitis externa at Evaluation 1.

• Systemic treatment with any anti-infective agent within 7 days (14 days for azithromycin) prior to Evaluation 1 or during the study.

• Treatment with a long-acting injectable antimicrobial agent (e.g., penicillin G benzathine) within 4 weeks prior to study drug administration.

• Concomitant infection, that requires additional antimicrobial therapy.

• Evidence of chronic, suppurative otitis media.

• Evidence of a physiologic, anatomic, or immunologic defect, which would interfere with resolution of this episode of acute otitis media.

• Presence of a disease, complicating factor (e.g., mastoiditis), or structural abnormality that would preclude evaluation of the subject's therapeutic response.

• Known, severe renal impairment (i.e., creatinine clearance < 30 mUmid1.73 m2).

• History of Augmentin-associated cholestatic jaundicehepatic dysfunction.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Birmingham	Alabama	United States	35211
2		Montgomery	Alabama	United States	36116
3		Ozark	Alabama	United States	36360
4		Mesa	Arizona	United States	85201
5		Scottsdale	Arizona	United States	85251
6		Little Rock	Arkansas	United States	72211
7		Clovis	California	United States	93612
8		Fresno	California	United States	93270
9		Longmont	Colorado	United States	80501
10		Fairfield	Connecticut	United States	06430
11		Marietta	Georgia	United States	30062
12		Stone Mountain	Georgia	United States	30087
13		Bardstown	Kentucky	United States	40004
14		Louisville	Kentucky	United States	40207
15		Owensboro	Kentucky	United States	42301
16		Ruston	Louisiana	United States	71270
17		Shreveport	Louisiana	United States	71105
18		Kalamazoo	Michigan	United States	49008
19		Richland	Michigan	United States	49083
20		Omaha	Nebraska	United States	68178
21		Las Vegas	Nevada	United States	89104
22		Columbus	Ohio	United States	43205
23		Medford	Oregon	United States	97504
24		Pittsburgh	Pennsylvania	United States	15241
25		Sellersville	Pennsylvania	United States	18960
26		Charleston	South Carolina	United States	29403
27		Austin	Texas	United States	78758
28		Lake Jackson	Texas	United States	77566
29		Salt Lake City	Utah	United States	84109
30		Salt Lake City	Utah	United States	84121
31		West Jordan	Utah	United States	84084
32		Vienna	Virginia	United States	22180

Sponsors and Collaborators

• Abbott

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00644943
• Other Study ID Numbers: M02-541
• First Posted: Mar 27, 2008
• Last Update Posted: Mar 27, 2008
• Last Verified: Mar 1, 2008

• Additional relevant MeSH terms: Otitis; Otitis Media; Amoxicillin; Cefdinir

Study Results

No Results Posted as of Mar 27, 2008